The government said on Wednesday that fears expressed by left parties that the new patent regime would push up drug prices were "misplaced" and noted that items like seeds and traditional knowledge were out of its purview.

"Impact on prices will be minimal. Drug prices will not go up as 97 per cent of the drugs are off patent," industry secretary Ashok Jha said.

In line with the World Trade Organisation obligations, India through an ordinance adopted product patent regime from January 1 for food, drugs and chemicals and embedded software with adequate safeguards to protect the interests of common man.

Only three per cent of the drugs were covered under the new patent regime and almost all of them have alternatives, he said adding product patents would help Indian pharma industry, which has made large investments in drug research.

"The new Patents Act is balanced, giving chance of drug development by frontline companies while protecting the interests of society at large and common man," he said.

There are checks and balances and safeguards like compulsory licensing will ensure that drugs are available at affordable prices, he said adding Indian drug prices are lowest in the world and studies show that drug prices have not gone up after "deflating the inflation" since trade related intellectual property rights came into being in 1995.

He also said traditional knowledge, seeds and over a dozen other items do not fall under the purview of patents and it was wrong to say that the country's farmers would be hit by the new regime.

"Price rise and patents have no correlation," Jha said, adding any price threat is "imaginary" as when some new drugs are patented, several old drugs go off the patent.

Also, there are only 350 essential drugs and none of them is a patented drug, he said. Jha said it is wrong to say that there was no consultation before the ordinance was brought in.

In fact since August 2003, all stakeholders, various departments, state governments, institutions and political parties have been consulted, he added.

Besides, the second amendment to patent law in 2002 was brought about after incorporating the recommendations of a Joint Parliamentary Committee in which all political parties were represented.

He also said the Mashelkar committee report was being "selectively quoted" by vested interests to say there are no adequate safeguards in the patent regime to check spurious drugs from flooding the market.

"It is not the patent law but the poor quality that threaten the smaller units, he said, adding quality is totally a separate issue. Adoption of good management practice was important for ensuring quality, he said, adding the government would soon come out with good manufacturing practices order.

The big companies already meet the standards to be proposed under GMPO and smaller companies too should start meeting those standards, he said. Jha made it clear that the new patent regime does not do away with the procedure for opposing a patent application.

The ordinance does provide for both pre-grant as well as post-grant opposition to patents and opportunity of hearing both before and after grant of patents.

In fact there has been some restructuring in this regard in the ordinance to ensure the procedure is now simpler, efficient, cost effective and user-friendly.

Of course, there is one change that is the ordinance provides a time frame for pre-grant opposition. Such opposition would have to be filed within three months of the publication of a patent application.

Jha said the ordinance has been brought about after going into various concerns expressed by different sections and then taking a balanced view.

"We have also taken note of some of concerns expressed by left parties," he added. With the Act coming into effect, the process of grant of product patents will get rolling as the government begins opening up of 'mail box' applications.

There are about 12,000 applications in the mailbox and it will take about three to four months to open these applications.

Of these 9000 pertained to pharma industry, including about 2000 from Indian drug companies. Jha also made it clear that patents would apply only prospectively.

It would take anything from three to five years to give a patent. Hence it would be at least three years before first patent is given under the new regime.